2021, Number 2
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Med Int Mex 2021; 37 (2)
Cardiovascular safety of antidiabetic drugs
González-Gálvez G, Castro-Martínez MG
Language: Spanish
References: 26
Page: 244-255
PDF size: 414.26 Kb.
ABSTRACT
Currently, any new drug for the treatment of type 2 diabetes needs cardiovascular outcome
studies to show regulators that they are safe drugs from a cardiovascular point of
view. DPP-4 inhibitors have fulfilled this requirement by demonstrating in these studies
the non-inferiority compared to placebo in the risk of cardiovascular events, showing
a neutral effect in this outcome. The GLP1 receptor agonists have shown that they are
not only safe, but they are also capable of achieving reduction in the development of
cardiovascular events and the SGLT-2 inhibitors have not only shown that they are
safe but also offer the benefit of reducing cardiovascular mortality and hospitalization
for heart failure early after its use and the potential for nephroprotection in secondary
analyzes of cardiovascular outcome studies.
REFERENCES
Seshasai SR, Kaptoge S, Thompson A, et al and the emerging risk factors collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med 2011; 364: 829-841. doi. 10.1056/NEJMoa1008862.
Alegre-Díaz J, Herrington W, López-Cervantes M, Gnatiuc L. et al. Diabetes and cause-specific mortality in Mexico City. N Engl J Med 2016; 375: 1961-1971.
Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356: 2457-2471. doi. 10.1056/ NEJMoa1605368.
Home PD, Pocock SJ, Beck-Nielsen H, Curtis PS, et al. Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicenter, randomized, open-label trial. Lancet 2009; 373: 2125-2135. doi. 10.1016/S0140-6736(09)60953-3.
US Food and drug administration guidance for industry: Diabetes Mellitus-Evaluating CV risk in new antidiabetic therapies to treat type 2 diabetes. Silver Spring, MD: Department of Health and Human Services, Center for drug evaluation and research, 2008. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm071627.pdf
European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. May 14, 2012. http://www.ema. europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500129256.pdf.
White WB, Cannon CP, Heller SR, Nissen SE, et al. Alogliptin after acute coronary syndrome in patients with T2D. N Engl J Med 2013; 369: 1327-1335. doi. 10.1056/ NEJMoa1305889.
Scirica BM, Bhatt DL, Braunwald E, Steg G, et al. Saxagliptin and CV outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013; 369: 1317-1326. doi. 10.1056/ NEJMoa1307684.
Zannad F, Cannon CP, Cushman WC, et al. Heart failure and mortality outcomes in patients with T2D taking alogliptin versus placebo in EXAMINE: a multicentre, randomised, double-blind trial. Lancet 2015; 385: 2067-2076. doi. 10.1016/S0140-6736(14)62225-X.
Green JB, Bethel MA, Armstrong PW, Buse JB, et al. Effect of sitagliptin on CV outcomes in Type 2 Diabetes. N Engl J Med 2015; 373: 232-242. doi. 10.1056/NEJMoa1501352.
Rosenstock J, Perkovic V, Johansen OE, Cooper ME, et al. Effect of Linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk. The CARMELINA randomized clinical trial. JAMA 2019; 321: 69-79. doi. 10.1001/jama.2018.18269.
Rosenstock J, Kahn SE, Johansen OE, Zinman B, et al. Effect of linagliptin vs glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes. The CAROLINA randomized clinical trial. JAMA 2019; 322: 1155-1166. doi. 10.1001/jama.2019.13772.
Pfeffer MA, Claggett B, Diaz R, Dickstein K, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med 2015; 373: 2247-2257. doi. 10.1056/ NEJMoa1509225.
Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2016; 375: 311-322. doi. 10.1056/ NEJMoa1603827.
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016; 375: 1834-1844. doi. 10.1056/NEJMoa1607141.
Holman RR, Betherl MA, Mentz RJ, Thompson VP, et al. Effects of once weekly exenatide on cardiovascular outcomes in type 2 diabetes. N Engl J Med 2017; 377: 1228-1239. doi. 10.1056/NEJMoa1612917.
Hernández AF, Green JB, Janmohamed S, D’Agostino RB, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony outcomes): a double-blind, randomized placebo-controlled trial. Lancet 2018; 392: 1519-1529. doi. 10.1016/S0140- 6736(18)32261-X.
Herstein HC, Colhoun HM, Dagenais GR, Díaz R, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomized placebo-controlled trial. Lancet 2019; 394: 121-130. doi. 10.1016/S0140- 6736(19)31149-3.
Zinman B, Wanner C, Lachin JM, Fitchett D, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015; 373: 2117-2128. doi. 10.1056/ NEJMoa1504720.
Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 2016; 375: 323-334. doi. 10.1056/ NEJMoa1611925.
Wiviott SD, Raz I, Bonaca MP, Mosenzon O, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med 2019; 380: 347-357. doi. 10.1056/NEJMoa1812389.
McMurray JJV, Solomon SD, Inzucchi SE, Kober L, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N.Engl.J.Med. 2019; 381: 1995-2008. doi. 10.1056/NEJMoa1911303.
Cannon CP, McGuire DK, Cherney D, et al. Results of the eValuation of Ertugliflozin EffIcacy and Safety CardioVascular Outcomes Trial (VERTIS CV). Presented at: 80th American Diabetes Association Scientific Sessions; June 16, 2020.
Gerstein HC, Bosch J, Dagenais GR, Díaz R, et al. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med 2012; 367: 319-28. doi. 10.1056/ NEJMoa1203858.
Marso SP, McGuire DK, Zinman B, Poulter NR, et al. Efficacy and safety of degludec versus glargina in type 2 diabetes. N Eng J Med 2017; 377 (8): 723-732. doi. 10.1056/NEJMoa1615692
Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the study of Diabetes (EASD). Diabetes Care 2018; 41: 2669-2701. doi. 10.2337/ dci18-0033.